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Official Title: a Phase 3, Randomized, Double-Blind, Placebo-Controlled Official Title: A Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of adjunctive pimavanserin for the treatment of schizophrenia NCT Number: NCT02970292 Date of IRB Approval: 30 Mar 2017 ACADIA Pharmaceuticals Inc. Clinical Study Protocol Amendment 2 A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin for the Treatment of Schizophrenia Protocol No. ACP-103-034 EudraCT Number: 2016-003434-24 Original Protocol Date: 29 August 2016 Amendment 1 Date: 28 November 2016 Amendment 2 Date: 30 March 2017 Confidentiality Statement This protocol is the confidential information of ACADIA Pharmaceuticals Inc. and is intended solely for the guidance of the clinical investigation. This protocol may not be disclosed to parties not associated with the clinical investigation or used for any purpose without the prior written consent of ACADIA Pharmaceuticals Inc. Confidential and Proprietary Information of ACADIA Pharmaceuticals Inc. Page 1 of 158 ACADIA Pharmaceuticals Inc. Protocol Amendment 2 Date: 30 March 2017 Protocol ACP-103-034 Amendment 2 SPONSOR CONTACT ACADIA Team Lead: Confidential and Proprietary Information of ACADIA Pharmaceuticals Inc. Page 3 of 158 ACADIA Pharmaceuticals Inc. Protocol Amendment 2 Date: 30 March 2017 Protocol ACP-103-034 Amendment 2 PROTOCOL SYNOPSIS Sponsor: ACADIA Pharmaceuticals Inc. Name of Study Drug: Pimavanserin Indication: Adjunctive treatment of schizophrenia Protocol Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin for the Treatment of Schizophrenia Protocol Number: ACP-103-034 EudraCT Number: 2016-003434-24 Objectives Primary Objective: To evaluate the efficacy of adjunctive pimavanserin compared with adjunctive placebo in the treatment of schizophrenia Secondary Objectives: To evaluate the safety and tolerability of adjunctive pimavanserin compared with adjunctive placebo in the treatment of schizophrenia To characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of adjunctive pimavanserin for the treatment of schizophrenia Methodology This study will be conducted as a Phase 3, 6-week, randomized, double- blind, placebo-controlled, multicenter, multinational outpatient study in subjects with schizophrenia with an inadequate response to current antipsychotic treatment. Schizophrenia is defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by a customized module of the Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT). This study will enroll approximately 380 subjects (190 subjects per treatment group) with schizophrenia and an inadequate response to antipsychotic medications. On the first day of the randomized treatment phase (Baseline), eligible subjects will be randomly assigned to receive adjunctive pimavanserin 20 mg per day or placebo daily in a 1:1 ratio, according to a computer-generated randomization schedule. The randomization will be stratified according to geographic region (North America, Europe, or rest of world). Subjects will participate in the study for up to 14 weeks, including a Screening Period of up to 4 weeks, a 6-week Treatment Period, and a 4-week safety follow-up (telephone call) for those subjects who discontinue prematurely from the study or who do not enroll in the 52-week, open-label extension study (Study ACP-103-035). Number of Study Approximately 70 study sites will participate in the study. Sites Confidential and Proprietary Information of ACADIA Pharmaceuticals Inc. Page 4 of 158 ACADIA Pharmaceuticals Inc. Protocol Amendment 2 Date: 30 March 2017 Protocol ACP-103-034 Amendment 2 Number of Approximately 380 subjects are planned for enrollment. Subjects Planned Diagnosis and Subjects who fulfill all of the inclusion criteria and none of the Main Criteria for exclusion criteria are eligible to enter this study. Inclusion and Inclusion Criteria: Exclusion Male or female, ≥18 and ≤55 years of age at the time of Screening Able to understand and provide signed informed consent Able to sign and date a request for medical records and/or subject privacy form if applicable according to local regulations In the Investigator’s opinion, is able to understand the nature of the trial, follow protocol requirements, be willing to comply with study drug administration, and discontinue prohibited concomitant medications Has a caregiver or some other identified responsible person (e.g., family member, social worker, caseworker, or nurse) considered reliable by the Investigator in providing support to the subject to help ensure compliance with study treatment, study visits, and protocol procedures and who is also able to provide input helpful for completing study rating scales Able to complete subject-reported outcome measures, can be reliably rated on assessment scales, and is willing to participate in audio recording of assessment scales and in an unrecorded telemedicine interview Diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria (confirmed using a customized module of the Structured Clinical Interview for DSM-5, Clinical Trials Version [SCID-5- CT]) Diagnosis of schizophrenia made ≥1 year prior to randomization Has been treated with an adequate dose of an antipsychotic within the dose range recommended according to the local Prescribing Information for at least 8 weeks prior to Screening and remaining at the same dose during the Screening Period. The subject may be taking a second antipsychotic at the time of Screening. Confidential and Proprietary Information of ACADIA Pharmaceuticals Inc. Page 5 of 158 ACADIA Pharmaceuticals Inc. Protocol Amendment 2 Date: 30 March 2017 Protocol ACP-103-034 Amendment 2 If the subject is taking two antipsychotics at Screening, the Investigator will: Determine which antipsychotic is the main antipsychotic Discontinue the other antipsychotic at least 5 half-lives before randomization Discontinue the other antipsychotic only if it is clinically appropriate; the other antipsychotic should not be discontinued solely to make the subject eligible for enrollment in the study The main antipsychotic with which the subject is being treated must be one of the antipsychotics listed below: Aripiprazole Aripiprazole long-acting injectables: Abilify Maintena® Aristada® Asenapine Brexpiprazole Cariprazine Lurasidone Olanzapine Risperidone Risperidone long-acting injection Has had a partial but inadequate response to the antipsychotic treatment If taking an oral antipsychotic, no dose change within 4 weeks prior to Screening or during the Screening Period If taking a long-acting injectable antipsychotic, no dose change within 16 weeks prior to Screening or during the Screening Period PANSS total score ≥65 and ≤110 at Screening and Baseline and there is no change in PANSS total score >30% from Screening to Baseline PANSS score ≥4 (moderate or worse) on at least two of the following items at both Screening and Baseline: Confidential and Proprietary Information of ACADIA Pharmaceuticals Inc. Page 6 of 158 ACADIA Pharmaceuticals Inc. Protocol Amendment 2 Date: 30 March 2017 Protocol ACP-103-034 Amendment 2 P1 (delusions) P3 (hallucinatory behavior) P6 (suspiciousness/persecution) A CGI-S score ≥4 (moderately ill or worse) at Screening and Baseline Has a history of response to antipsychotic treatment other than clozapine Must be medically stable and has been medically stable for at least 12 weeks prior to Screening, in the opinion of the Investigator If female, must be of non-childbearing potential (defined as either surgically sterilized or at least 1 year postmenopausal) or must agree to use two clinically acceptable methods of contraception (e.g., oral, intrauterine device [IUD], diaphragm plus spermicide, injectable, transdermal or implantable contraception). All females must have a negative serum human chorionic gonadotropin (hCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline Exclusion Criteria: Based on the SCID-5-CT, has a current comorbid psychiatric disorder other than schizophrenia (e.g., bipolar disorder, obsessive compulsive disorder, substance abuse) or a disorder that would interfere with the ability to complete study assessments (e.g., intellectual disability) Has a history of resistance to antipsychotic treatment, as defined by either of the following criteria: Failed to show even minimal response to ≥2 adequate antipsychotic medications prescribed at adequate doses for adequate length of time; failure to tolerate a medication does not constitute failure to respond History of treatment with clozapine for refractory psychosis or use of clozapine within the past 12 weeks prior to Screening Confidential and Proprietary Information of ACADIA Pharmaceuticals Inc. Page 7 of 158 ACADIA Pharmaceuticals Inc. Protocol Amendment 2 Date: 30 March 2017 Protocol ACP-103-034 Amendment 2 Is at a significant risk of suicide, or is a danger to self or others, in the opinion of the Investigator Has a significant risk of violent behavior in the opinion of the Investigator Has met DSM-5 criteria for substance use disorders within the last 6 months prior to randomization (other than caffeine and/or nicotine) A urine drug screen result at Screening or Baseline that indicates the presence of any tested prohibited substance of potential abuse, except marijuana Subjects
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